CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients

Cytomegalovirus (CMV) is a significant opportunistic pathogen and a major cause of morbidity and mortality in solid organ transplant recipients. CytoGam - Cytomegalovirus Immune Globulin Intravenous (CMV-IGIV), is an immunoglobulin G containing a standardized amount of antibody against CMV. CytoGam is obtained from pooled adult human plasma that has been selected for high anti-CMV titers. This study will evaluate if administration of CytoGam to organ transplant recipients with CMV infection, along with standard of care antiviral medication, leads to faster clearance of CMV from the blood, prevents the development of antiviral resistance, and decreases the rate of recurrence of CMV infection.

NCT Number	NCT07009548
Lead Sponsor	Fernanda P Silveira, MD, MS Collaborators: Kamada, Ltd.
Conditions	Cytomegalovirus (CMV) Infection
Enrollment	45 participants
Start Date	2025-06-26
Primary Completion	2027-12 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-08-10